COVID-19, Pneumonia
Conditions
Brief summary
The purpose of this study is to determine the safety and efficacy of the drug ruxolitinib in people diagnosed with COVID-19 pneumonia by determining the number of people whose conditions worsen (requiring machines to help with breathing or needing supplemental oxygen) while receiving the drug. This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network and other centers.
Detailed description
Multifocal interstitial pneumonia is the most common cause of deterioration in people with COVID-19. This is attributed to a severe reaction where releases too many cytokines (proteins that play an important role in immune responses) which rush into the lungs resulting in lung inflammation and fluid buildup. This can lead to damage to the lungs and leading to breathing problems. Ruxolitinib when given early in the disease, may prevent the overproduction of cytokines which, in turn, may prevent lung damage.
Interventions
DRUGRuxolitinib
Ruxolitinib is an inhibitor of JAK1 and JAK2 (proteins important in cell signalling) approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COVID-19 infection diagnosed by nasopharyngeal sample * Need for supplemental oxygen to maintain oxygen saturation \> 93% * 12 years of age or older
Exclusion criteria
* Neutrophils \< 1 x 10\^9/L * Platelets \< 50 x 10\^9/L * Serum total bilirubin \>2.0 x upper limit of normal (ULN) * Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) \> 5x ULN * Creatinine clearance (CrCl) \< 15 mL/minute * Pregnant women * Known HBV or HIV infection * Signs and symptoms of Varicella Zoster Virus (VZV) infection * Patients requiring invasive mechanical ventilation. Patients requiring non-invasive mechanical ventilation (e.g., BiPAP) are eligible. * Patients who require supplemental oxygen support prior to COVID-19 infection. * Patients who are on ruxolitinib or similiar drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more) | 6 months |
| Number of adverse events | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality rate | 9 months |
| Average duration of hospital stay | 9 months |
Countries
Canada
Outcome results
None listed